SUPPLY CHAIN ARTICLES

  • Therapeutic Oligonucleotides: Regulations & Quality Standards

    Oligonucleotides have surfaced in the past few years as promising therapeutic agents to treat diseases such as neurodegenerative disorders, respiratory disorders, cancer, and diabetic retinopathy. This article recaps a recent USP workshop where participants from regulatory agencies, industry, and academia gathered to discuss best practices and perspectives.

  • Biomanufacturing Capacity Crunch: It's The Supply Chain's Fault

    What's behind the protracted biopharma manufacturing capacity crunch, when will it end, and what are manufacturers doing to keep supply on track? During Biotech Week in Boston ad BioProcess International, CDMOs and sponsors weighed in.

  • Inside Alnylam's Playbook For High Volume siRNA Production

    As one of the first companies to establish a chemoenzymatic ligation platform, Alnylam's Maines and Nechev are in the perfect position to espouse wisdom on the practical aspects and remaining challenges of implementing enzymatic ligation at a large scale. Here in this installment, Maines and Nechev outline what they’ve learned thus far about the science of enzymatic ligation, while also paying credence to the unknowns and existing barriers that, as a frontrunner, Alnylam will inevitably (but willingly) be tasked with facing in the future.

  • FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities

    The FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.

  • From Misinformation To Medicine: Forging Bipartisan Support to Reverse Anti-mRNA Policy

    In this article, I’ll share some of the progress AMM has made and the barriers the organization/our industry is still facing in our efforts to reverse the policy decisions that have been made against mRNA today. Throughout the panel, the speakers also shared their thoughts on the types of messaging we should be considering and/or have started to see making an impact. 

  • Innovations In The Oligonucleotide Supply Chain: Regulatory Considerations For Materials, Manufacturing, And Lifecycle Control

    Oligonucleotide therapeutics have rapidly advanced into late-stage and commercial development, shifting regulatory focus toward the maturity of manufacturing and supply chain control rather than therapeutic novelty. Regulatory success now depends on how effectively sponsors translate innovative chemistries into well-characterized, scalable, and sustainable materials and processes.

SUPPLY CHAIN VIDEOS

Explore a state-of-the-art GMP facility focused on CRISPR based Cell and Gene therapies with helping temperature controlled warehouse and multiple synthesis suites.

Advancing RNA Live panelists Tyler Goodwin and April Sena start off our latest discussion on technology innovations in mRNA production by surveying the current manufacturing process for plasmid production, highlighting where they’ve seen advancements and what biotechs need to consider to obtain plasmids of the appropriate quality for mRNA production.

There remain a lot of gaps in our understanding of plasmid quality, particularly for high-quality mRNA production (as opposed to viral vector production). In this segment of a recent Advancing RNA Live panel, speakers Adi Nair, Tyler Goodwin, and April Sena highlight their biggest questions around plasmid DNA quality, as well as the pros and cons of some of the analytical methods upon which we’re relying most heavily today to assess plasmid quality.

This Advancing RNA Live clip dives into the biggest challenges in mRNA purification and the critical debate on where to focus investment. Here, our three mRNA PD experts argue for a holistic process development strategy, challenging the traditional wisdom of optimizing the upstream process at any cost.

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